The Pivotal study has showed that MiniMed® ™ 670G can be used by adolescents and adults with Type 1 diabetes in an outpatient setting with no episodes of severe hypoglycaemia and DKA in over 12,000 patient days of use.

The SmartGuard® Auto Mode feature was associated with significant HbA1c reduction, from baseline, 7.8% to 7.2% in adolescents and 7.4% to 6.9% in adults.

Additionally the SmartGuard® Auto Mode feature was associated with an increased time spent in glycaemic target range (3.9-10.0mmol/L), reducing both hypoglycaemia and hyperglycaemia, in both adolescents and adults.

Multi-centre, unblinded randomised controlled phase 3 home trial over six months. 154 participants with type 1 diabetes aged 8-20 years on MiniMed® 640G were randomised to have the automatic suspend before low function on or off for the duration of six months.

Result:

Children and adolescents spent approximately half the time in hypoglycaemia with fewer hypoglycaemic events with Suspend Before Low ON as compared with Suspend Before Low OFF.

The lower hypoglycaemia exposure was consistent in subgroups of participants irrespective of age, duration of diabetes, HbA1c and hypoglycaemia awareness status.

The reduction in hypoglycaemia was not associated with a deterioration of glucose control as measured by hyperglycaemia or HbA1c, nor in a reduction in quality of life.

The aim was to determine the effectiveness of Pedictive Low Glucsoe Management (PLGM) in preventing insulin induced hypoglycemia in two controlled in-clinic conditions, 1. excess insulin Bolus™ during the day and 2. increased basal insulin delivery overnight. The design for the insulin Bolus™ protocol was a three-centre, randomized, controlled, crossover trial (n = 28). The design for the increased basal protocol was similar but a single centre (n = 8) with 180% night-time basal rates. For both conditions the PLGM algorithm was set to suspend insulin at sensor glucose predicted to be <80 mg/dL (4.4 mmol/L) within 30 mins, and the control condition was SAPT alone with no insulin suspension. The primary outcome was need for hypoglycaemia treatment, either due to symptoms or plasma glucose <50 mg/dL (2.8 mmol/L).

Result:

SAPT with PLGM substantially reduced the requirement for hypoglycemia treatment following insulin induced hypoglycemia in an in-clinic setting